Job Listing: Clinical Trial Specialist

Aerotek's client in Waltham is looking for a Clinical Trial Specialist to join their team. Our client is a leading global bio/pharmaceutical services organization that helps clients expedite time-to-market through their development and launch services. These include a broad range of clinical development capabilities, integrated advanced technologies, regulatory affairs consulting, and commercialization services. The Clinical trial Specialist's essential function will be to negotiate contracts between sponsors and sites and collect and review site regulatory documents. Any interested Proposal and Contract Developer should email Word version of resume to szaitchi@aerotek.com.

Responsibilities:
-Negotiate contracts between sponsor and sites.
-Collect and review site regulatory documents.
-Project tracking to meet the project related timelines and contractual obligations.
-Review and approve investigator site regulatory package documents (Statement of Investigator, CVs, IRB/IEC approval documentation, informed consent form documents, etc.).
-Work with the appropriate project team members to resolve issues and
queries related to SRPs.
-Maintain a working knowledge of, and assure compliance with, applicable ICH Guidelines, Good Clinical Practices, Regulatory Agency requirements, and SOPs.
-Participate in Clinical Operations meetings and training initiatives, project team meetings, and maintain relationships with other departments, clients, and regulatory agencies as necessary.
-Participate in department system/standards improvement activities.
-Provide weekly trackers and accurate monthly metrics in a timely manner to Clinical Operations management.

Requirements:
-The ideal candidate will have 2 years of in contract negotiation, site regulatory document collection and review, and/or clinical site monitoring experience.
-Strong regulatory or ICF knowledge.
-Ability to work in a demanding environment.
-Current role could be described as a combination Collector/Reviewer.
-Must be comfortable communicating directly with Sponsors (i.e. team liaison when necessary).
-Familiar with developing SRP guidelines (they call this Investigator Package Plan) and Inform Consent Models.
-Must be able to multitask and keep each study straight.
-Candidate must be very detailed oriented, hard working, organized, good communicator, very hands on and likes working/mentoring new hires.
-Candidate must be familiar with the start-up process.

Required Skills for Clinical Trial Specialist Job:

About Aerotek Scientific:

Join Aerotek Scientific LLCSM, one of the fastest growing providers of scientific and clinical research services in the nation. Due to our growth, we're constantly on the lookout for qualified professionals to place in contract, contract-to-hire, and permanent placement positions across the scientific and clinical research communities. At Aerotek Scientific, we know it's more than just your day-to-day responsibilities that can make or break a job. It's the support you get. That's the reason Aerotek Scientific offers a variety of benefits including medical, dental, optical, 401k, and many more. Don't put your career in the hands of just anyone, put it in the hands of a specialist. Join the Aerotek Scientific team! Allegis Group and its subsidiaries are equal opportunity employers.